Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Schering-Plough |
---|---|
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00237484 |
This is a Phase IIIB, randomized, prospective, multicenter, single-country, open-label, controlled pilot trial designed to evaluate the effect of infliximab induction therapy on sustained virologic response (SVR) to treatment with pegylated interferon alfa-2b plus ribavirin in a group of 96 therapy-naïve subjects with genotype 1 hepatitis C virus (HCV) infection and high serum tumor necrosis factor (TNF)-alpha values.
Condition | Intervention | Phase |
---|---|---|
Hepatitis C, Chronic |
Drug: Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin Drug: Combination of (a) pegylated interferon alfa-2b and (b) ribavirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Infliximab in Hepatitis-C Genotype 1 Naïve Patients With High TNF-Alpha on the Efficacy of Pegylated Interferon Alfa-2b/Ribavirin Therapy |
Estimated Enrollment: | 96 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm A: Experimental
Remicade induction dose at Day -7 prior to initiation of PEGETRON treatment for up to 48 weeks
|
Drug: Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin
|
Arm B: Active Comparator
PEGETRON treatment for up to 48 weeks
|
Drug: Combination of (a) pegylated interferon alfa-2b and (b) ribavirin
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Compensated liver disease with the following minimum hematological, biochemical, and serological criteria at the screen visit (WNL = within normal limits):
Exclusion Criteria:
Any known pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study such as:
Severe depression includes the following:
Any cause of liver disease other than chronic hepatitis C, including but not limited to:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
Canada | |
Investigational Site 1 | Recruiting |
Ottawa, Canada, K1H 8L6 | |
Investigational Site 4 | Recruiting |
Edmonton, Canada, T6G 2B7 | |
Investigational Site 5 | Recruiting |
Toronto, Canada, M3N 2V7 | |
Investigational Site 7 | Recruiting |
Vancouver, Canada, V6K 2A5 | |
Investigational Site 12 | Recruiting |
Toronto, Canada, M6H 3M1 | |
Investigational Site 8 | Recruiting |
Saskatoon, Canada, S7N OW8 | |
Investigational Site 9 | Recruiting |
Vancouver, Canada, V6A 4B6 | |
Investigational Site 2 | Completed |
Vancouver, Canada, V6Z 2C7 |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04257 |
Study First Received: | October 10, 2005 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00237484 |
Health Authority: | Canada: Health Canada |
pegylated interferon alfa-2b ribavirin infliximab chronic hepatitis C |
Interferon-alpha Interferon Type I, Recombinant Liver Diseases Hepatitis, Chronic Infliximab Interferons Ribavirin Hepatitis, Viral, Human |
Hepatitis Virus Diseases Digestive System Diseases Peginterferon alfa-2b Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic Interferon Alfa-2b |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Gastrointestinal Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Antirheumatic Agents Dermatologic Agents |